Are the Continuous Glucose Monitoring Systems Able to Improve Long Term Glycaemic Control in Type 1 Diabetic Patients?
Are the Continous Glucose Monitoring Systems Able to Improve Long Term Glycaemic Control in Type 1 Diabetic Patients With Poor Metabolic Control?
1 other identifier
interventional
180
2 countries
19
Brief Summary
The "Capteur Evadiac" study group, composed of French and Belgian diabetologists, has designed a 1 year randomized controlled multicenter study in order to define what should be the best clinical way of using continuous glucose monitoring in the long term to improve metabolic control in uncontrolled type 1 diabetes patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2008
Typical duration for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 23, 2008
CompletedFirst Posted
Study publicly available on registry
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFebruary 9, 2012
April 1, 2011
2.3 years
July 23, 2008
February 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of HbA1c mean between the 3 groups
at 1 year
Secondary Outcomes (7)
Comparison of glucose stability in the 3 groups
inclusion, M3, M6, M9, M12
Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period
study period
Frequency of symptomatic benign hypoglycaemic episodes during the week prior to each visit. inclusion and prior to M3, M6, M9, M12
prior to inclusion and prior to M3, M6, M9, M12
Comparison of HbA1c in patients treated by pump to those treated by multiple daily injection
inclusion, M3, M6, M9, M12
Evaluation of the Quality of Life (DQOL and SF36) and patient's satisfaction in the 3 groups
inclusion and M12
- +2 more secondary outcomes
Study Arms (3)
Group1-patient
ACTIVE COMPARATORThe patient will be encouraged to use the Navigator® all the time and to modify his treatment according to the continous blood glucose measurements. The patients will follow an educational process in order to adapt insulin doses according to each sensor data.
Group2-diabetologist
ACTIVE COMPARATORThe patient will follow the same educational process as group 1 concerning insulin dose adaptation. They will use the continous glucose monitoring device according to the diabetologist's prescription and they will receive precise instructions to make considering results. The duration of the use of the Navigator® will be increased if one of the following criteria is observed at the consultation each 3 months: * HbA1c\>=7.5% * 1 severe hypoglycaemia or more * More than 4 benign hypoglycaemia per week According to these criteria, every 3 months, the duration of the use of the monitoring system will be increased as following: * step 1: 3 sensors per month * step 2: 4 sensors per month * step 3: 5 sensors per month * step 4: continuous use
Group3-Control
PLACEBO COMPARATORUsual follow up with self-monitoring blood glucose.
Interventions
Patients will be encouraged to use the Navigator® all the time and to modify their treatment according to the device measurments. Patients will also follow and educational process in order to adapt insulin doses according to each sensor data
Patients will have their usual follow up with self-monitoring blood glucose
Eligibility Criteria
You may qualify if:
- Type 1 Diabetes for ≥ 12 months or more (including Cpeptide negative secondary diabetes)
- Children between 8 and 18 years old
- Adults between 18 and 60 years old
- Patients treated with basal-bolus insulin regimens, pump or multiple daily injection, only with analogs, for at least 6 months
- Performing at least 2 finger sticks glucose controls per day
- Able and motivated to use the device
- HbA1c ≥ 8% twice with HPLC method(DCA 2000 excluded)
- Written informed consent obtained prior to enrollment in the study
You may not qualify if:
- Blindness or impaired vision so the screen cannot be recognized
- Allergy to sensor
- Active proliferative retinopathy not stabilized by laser or vitrectomy occurence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during study
- Treatment with systemic corticosteroid or medication known to influence insulin sensitivity in the 3 months prioir to visit 1
- Pregnancy
- Manifest psychiatric disturbance
- Presence of any conditions (medical, including clinically significant abnormal laboratory test, psychological, social or geographical) actuel or anticipated that the investigators feels would compromise the patient safety or limit his/her successful participation in the study.
- Hemoglobinopathy that interfers with HbA1c measurement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
CHU Sart Tilman Liège
Liège, 4000, Belgium
CHU Jean Minjoz
Besançon, Besancon, 25030, France
CH SUD Francilien
Corbeil-Essonnes, Corbeil Essonnes, 91100, France
University Hospital Grenoble
Grenoble, Grenoble, 38043, France
Hopital Edouard Herriot
Lyon, Lyon, 69003, France
CHU Marseille Hôpitaux Sud
Marseille, Marseille, 13274, France
Chu Montpellier
Montpellier, Montpellier, 34295, France
CHU Hôpital Jeanne d'Arc
Nancy, Nancy, 54201, France
CHU Nantes
Nantes, Nantes, 44093, France
Hopital Hotel Dieu
Paris, Paris, 75004, France
Hopital Haut Leveque
Pessac, Pessac, 33604, France
CHU Rennes
Rennes, Rennes, 35056, France
Hopital Bellevue
Saint-Etienne, Saint Etienne, 42055, France
CHU Toulouse
Toulouse, Toulouse, 31403, France
CHU La Pitié Salpetrière
Paris, 75013, France
CHU Robert Debré
Paris, 75019, France
CHU de Reims-Hôpital Américain
Reims, 51100, France
CHU de Reims-Hôpital Robert debré
Reims, 51100, France
CHU Strasbourg
Strasbourg, 67091, France
Related Publications (1)
Riveline JP, Schaepelynck P, Chaillous L, Renard E, Sola-Gazagnes A, Penfornis A, Tubiana-Rufi N, Sulmont V, Catargi B, Lukas C, Radermecker RP, Thivolet C, Moreau F, Benhamou PY, Guerci B, Leguerrier AM, Millot L, Sachon C, Charpentier G, Hanaire H; EVADIAC Sensor Study Group. Assessment of patient-led or physician-driven continuous glucose monitoring in patients with poorly controlled type 1 diabetes using basal-bolus insulin regimens: a 1-year multicenter study. Diabetes Care. 2012 May;35(5):965-71. doi: 10.2337/dc11-2021. Epub 2012 Mar 28.
PMID: 22456864DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jean-Pierre Riveline, MD
CH Sud Francilien
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2008
First Posted
August 1, 2008
Study Start
February 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
February 9, 2012
Record last verified: 2011-04